Hydrocortisone
- Product NDC
- 0472-0337
- 11-digit product format
- 004720337
- Labeler code
- 0472
- Product ID
- 0472-0337_fa21d1bb-b3b7-4ff9-93b9-29adb6312fc9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA089682
- Marketing category
- ANDA
- Marketing start
- 2002-09-30
- Marketing end
- 2026-06-30
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocortisone
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 310891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0472-0337-20 | Hydrocortisone | 20 g in 1 TUBE | CREAM | 20 | | 8 |
| 0472-0337-20 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | | 8 |
| 0472-0337-30 | Hydrocortisone | 30 g in 1 TUBE | CREAM | 30 | | 8 |
| 0472-0337-30 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | HYDROCORTISONE CREAM [ACTAVIS MID ATLANTIC LLC] | 3 | |
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | HYDROCORTISONE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0472-0337 | HYDROCORTISONE CREAM [ACTAVIS PHARMA, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20201028_a5f16c13-2a51-4541-bf9e-d80bc01a8dbd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0472-0337-20 | 00472033720 | 1 TUBE in 1 CARTON (0472-0337-20) / 20 g in 1 TUBE | 1 tube | 2002-09-30 | 2026-05-31 | No | No | Current |
| 0472-0337-30 | 00472033730 | 1 TUBE in 1 CARTON (0472-0337-30) / 30 g in 1 TUBE | 1 tube | 2002-09-30 | 2026-06-30 | No | No | Current |